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November 2, 2005
The Flu Plan, Part One: Vaccines
Posted by Derek
The government's proposed plan for dealing with a flu pandemic is worth some comment, although it's going to undergo mutations just as surely as the viruses do. It's hard to argue with the overall approach, but there are some details that need explaining.
For example, there's a proposed boost for research into vaccine production through cell culture techniques (as opposed to the famous chicken-egg methods), and I think that this is a fine idea. Unfortunately, it was just as fine an idea two or three years ago, and we'd probably be in better shape now if this idea had been pushed back then. Money doesn't convert to time quite as easily in basic research as it does in some other areas (although it doesn't hurt, true). Some of the companies that do work in this area are pointing this out today, in rather testy tones of voice:
. . .so far the government has not backed development of three cell-based vaccines that have received or are close to receiving regulatory approval in the United States and Europe - including one developed by a Meriden (CT) biotechnology company. Instead, the Department of Health and Human Services last April funded only one cell-based flu vaccine - $97 million for a vaccine that has not yet been tested in animals or humans.
"I don't know what the hell they are thinking about," said Dan Adams, president and chief executive officer of Protein Sciences. . ."
This is the voice of a man whose company missed out on a $97 million dollar contract, so that has to be taken into account. But it does appear that HHS and the FDA have been overly cautious about moving to cell-culture based vaccines.
But "caution" is a popular word in the vaccine field, in the financial, medical, and legal senses. and that brings up another provision in the President's proposal that I haven't seen anyone else comment on yet: liability protection for vaccine producers. As you might figure, I think that this is on principle a good idea, but the trial lawyers (and some others) will think differently. This will be an interesting fight, but it might take place largely out of sight. "Fight for your right to sue the people who are trying to protect you from bird flu" isn't a very catchy slogan.
My last comment on vaccines in this context is to point out that - cell culture or no cell culture - if we get to the point that we're relying on a vaccine to save people from a pandemic, then we could be in big trouble. There's an inevitable delay in vaccine development and production - months and months and months of delay, and that's when things are really zipping along. Viruses can mutate in the time it takes to fight their previous versions. If we're lucky, the vaccines that are being developed now will have enough protective effect against whatever flu strain might cause a pandemic. But they might well not, and we need to realize that.
Comments (4)
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1. wcw on November 3, 2005 12:48 AM writes...
In re: liability protection for flu vaccine producers, your idea is so good it's already happened. More than once.
Specific to influenza, the "American Jobs Creation Act" (cough) added flu vaccine to the National Vaccine Injury Compensation Program in 2004. I'm hardly expert, but that program has been running for pushing two decades now, and childhood vaccine production seems not to have ceased due to tort claims.
Further, it is my impression that the administration can at any time, by executive order, immunize flu vaccine makers from lawsuits just as it has already done for smallpox.
Maybe -- just maybe -- George Bush is pushing "liability protection for vaccine producers" for some other reason. Perhaps -- just perhaps -- the words for which you are searching are "thimerosal" and "Eli Lilly". I am agnostic on Lilly's putative liability, but the evidence points to this being yet another "Healthy Forests" initiative.
Permalink to Comment2. Diana on November 3, 2005 12:28 PM writes...
"Fight for your right to sue the people who injure or kill you from a bird flu vaccine under the declaration of a heathcare emergency with 'any means necessary' to force vaccination under military law enforcement" isn't a very catchy slogan either...
The president said the United States must approve liability protection for the makers of lifesaving vaccines. He said the number of American vaccine manufacturers has plummeted because the industry has been hit with a flood of lawsuits.
Do you support the waiver of liability language for a security countermeasure, or a qualified pandemic and epidemic product, put forth in S. 1873 - Biodefense and Pandemic Vaccine and Drug Development Act of 2005, October 17, 2005?
SEC. 6. LIABILITY PROTECTIONS FOR PANDEMICS, EPIDEMICS, AND COUNTERMEASURES.
(a) Authority- As provided in subsection (b), and subject to subsection (b)(1)(C), a manufacturer, distributor, or administrator of a security countermeasure, or a qualified pandemic and epidemic product, described in subsection (b)(1)(A) or a health care provider shall be immune from suit or liability caused by or arising out of the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a security countermeasure, or a qualified pandemic and epidemic product, described in subsection (b)(1)(A).
(b) Litigation Management-
(1) LIMITATION ON CAUSE OF ACTION-
(i) IN GENERAL- No cause of action shall exist against a person described in subsection (a) for claims for loss of property, personal injury, or death arising out of, reasonably relating to, or resulting from the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a security countermeasure or qualified pandemic or epidemic product distributed, sold, purchased, donated, dispensed, prescribed, administered, or used in anticipation of and preparation for, in defense against, or in response to, or recovery from an actual or potential public health emergency that is a designated security countermeasure or a qualified pandemic or epidemic product by the Secretary in a declaration described in paragraph (2).
I do not believe that discussions regarding vaccine safety and liability should take place largely out of sight as put forth in S. 1873. The newly created Biomedical Advanced Research and Development Agency (BARDA) shall not be subject to disclosure under section 552 of title 5, United States Code (a.k.a. the Freedom of Information Act or FOIA) regarding information that relates to its activities, working groups, and advisory boards.
The agency would be exempt from the Freedom of Information Act and from the Federal Advisory Committee Act, which requires public transparency -- making it almost certain that no evidence of injuries or deaths caused by drugs and vaccines labeled as "countermeasures" to bioterrorism or new disease epidemics would ever become public.
Maybe -- just maybe -- George W. Bush is pushing "liability protection for vaccine producers" for some other reason. Perhaps -- just perhaps -- the words for which you are searching are "thimerosal" and "Eli Lilly". The bird-flu H5N1 vaccine with a $100 million contract award last month to the sole provider, Sanofi Pasteur, still contains 25 micrograms of ethyl mercury.
And let's not forget that in the past six months fears of a pandemic and the ensuing scramble for Tamiflu have sent Gilead Science's stock from $35 to $47. That Donald Rumsfeld, Pentagon Chief, served as Gilead (Research)'s chairman from 1997 until he joined the Bush administration in 2001, and he still holds a Gilead stake valued at between $5 million and $25 million. The share increase has made Rumsfeld at least $1 million richer. And although Rumsfeld said he would not participate in any way in the development and acquisition by the government of vaccines and treatments for bird flu, he will still participate in issues involving possible quarantines and use of military personnel in any outbreak, as well as the delivery of humanitarian assistance by the military - with no liability for the administration of a security countermeasure, or a qualified pandemic and epidemic product.
Permalink to Comment3. Daniel Newby on November 3, 2005 5:37 PM writes...
Is it technically feasible to synthesize a peptide vaccine from scratch? Sure it would be expensive, but cost effective has a different meaning when a pandemic's mortality rate is 25%.
Permalink to Comment4. Jim Hu on November 3, 2005 7:08 PM writes...
Sythesizing the peptide vaccine isn't the problem, as far as I know...it's my impression that very few peptide vaccines have worked...so far. The Human Papilloma Virus vaccines in the news are an exception.
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